Day Two

Thursday, 21st March 2013

8.00 Registration, Coffee & Networking

8.55 Chair’s Opening Remarks

Stacey Tannenbaum, Director, Astellas Pharmaceuticals

PK/PD Modeling & Simulation To Determine An Appropriate Dosage Regimen And Reduce The Risk Of Toxicity In The Clinic

9.00 AMG X Toxicokinetics, Toxicodynamics and Off-target Platelet Activation in Macaques - Unique Challenges for Preclinical and Clinical Development of Therapeutic Monoclonal Antibodies

• In vitro pharmacology of AMG X

• In vivo TK/TD of AMG X in cynomolgus monkeys

• Development challenges for therapeutic monoclonal antibodies

Wei-Jian Pan, Principal Scientist, Amgen

9.30 Dose Selection for a Phase II by Integrating Preclinical and Clinical Data

• Common challenges surrounding the appropriate selection of dose regimen

• Case Study: PK/PD model for dose selection

• What PK/PD parameters are necessary to establish the maximum recommended safe dose?

Holly Kimko, Scientific Director, Janssen

10.00 Mastermind Session

10.30 Morning Refreshments

11.00 Understanding the Root Causes of PK Variability to Inform De-Risking Strategies in Early Development

• Evaluating the risk of PK variability for any molecule transitioning to development

• Understanding the importance of route of administration, species dose and other physiological parameters

• Identifying the in vitro and in vivo risk assessment of PK variability as well as mitigation approaches

Pierre Daublain, Senior Research Chemist, Merck

11.30 Panel Discussion: What is the Best Strategy for Selecting the Maximum Safe Dose for First-Time Clinical Trials?

• Which safety parameters tell you that the maximum clinical dose has been reached?

• What alternatives are available to address the issues?

Wei-Jian Pan, Amgen; Lucy Lee, Eisai; Patrick Trapa, Pfizer

12.00 Lunch

1.00 Pharmacokinetic/pharmacodynamic models to predict synergistic effects of co-administered anti-cancer agents

• Effectively combining data sets to avoid pursuing false positives

• Addressing the limitations in data sets to ensure that the best decisions are made moving forward

• Strategies for selecting the maximum recommended safe dose

Kosalaram Goteti, Senior Clinical Pharmacokineticist, MedImmune

1.30 Experiences in Optimal Design for Population PK/PD Models

• A detailed overview of population PK/PD in drug development

• Optimizing the design for population PK/PD models throughout the drug pipeline

• Addressing the limitations of current PK/PD software tools

Timothy Waterhouse, Senior Research Scientist, Eli Lilly

2.00 Afternoon Refreshments

2.30 Using Longitudinal Solid Tumor Data to Better Characterize Dose-Response in Oncology Clinical Trials

• Supporting dose selection and Phase II go/no-go decision making using single value efficacy endpoints

• Determining the probability of success using the limited supportive information available

• Utilizing quantitative modeling methods to improve confidence in the predictions of Phase III outcome

Andrew Stein, Senior Modeller, Novartis

Appropriate PK/PD Modeling & Simulation To Ensure The Best Decision Criteria Is Chosen In Clinical Development

3.00 The Application of PK/PD Modeling and Simulation During Lead Optimization

• Overcoming the challenges of PK/PD modeling and simulation at candidate selection

• Dealing with the rising costs of developing new and innovative drugs

• Identifying the appropriate PK/PD approach in prioritizing candidates

3.30 Modeling and Simulation Application in Anti-Addiction Treatment Development

• Identifying a strategy for addiction treatment to accelerate drug metabolism

• Appropriate PK/PD modeling to ensure that decisions are made with confidence

• Overcoming common challenges in PK/PD data for higher success in the clinic

Linghui Li, Clinical PK/PD Scientist, Novartis

4.00 Chair’s Closing Remarks

Stacey Tannenbaum, Director, Astellas Pharmaceuticals